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High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX® PRO System, UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma bv rate turbidimetry.

Clinical Significance:
Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.

High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry. SYNCHRON® System(s) CRPH reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity.

Here's an analysis of the provided text regarding the SYNCHRON® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent, addressing your specific questions:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence to previously cleared devices through performance data rather than defining explicit acceptance criteria in the typical sense of a target performance metric (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by the demonstration that the new device performs comparably to the predicate device and meets established analytical performance standards (linearity, imprecision).

The study that "proves the device meets the acceptance criteria" is the Summary of Performance Data presented in section 8.0.

1. Table of Acceptance Criteria and the Reported Device Performance

0.2 to 10 mg/L range:
Slope: 1.030
Intercept: -0.008
Correlation Coefficient (r): 0.9910 |
| Imprecision | Low variability (e.g., %CV within acceptable clinical laboratory limits) | Within-Run Imprecision (N=80 for each level):

• Level 1 (Mean 0.063 mg/dL): S.D. 0.0019 mg/dL, %C.V. 3.1
• Level 2 (Mean 1.368 mg/dL): S.D. 0.0222 mg/dL, %C.V. 1.6
• Level 3 (Mean 5.639 mg/dL): S.D. 0.0907 mg/dL, %C.V. 1.6

Total Imprecision (N=80 for each level):

• Level 1 (Mean 0.063 mg/dL): S.D. 0.0033 mg/dL, %C.V. 5.3
• Level 2 (Mean 1.368 mg/dL): S.D. 0.0381 mg/dL, %C.V. 2.8
• Level 3 (Mean 5.639 mg/dL): S.D. 0.1823 mg/dL, %C.V. 3.2 |
  | Linearity | Not explicitly detailed in the provided summary, but mentioned as performed | |
  | Stability | Not explicitly detailed in the provided summary, but mentioned as performed | |

2. Sample size used for the test set and the data provenance

• Sample Size (Method Comparison):
  • 269 samples for the 0.2 to 80 mg/L range comparison.
  • 149 samples for the 0.2 to 10 mg/L range comparison.
• Sample Size (Imprecision): 80 replicates for each of the 3 levels tested (total 240 measurements for within-run, and 240 for total imprecision).
• Data Provenance: Not explicitly stated in the provided document (e.g., country of origin, retrospective or prospective). This information is typically found in the full study report, not necessarily in a 510(k) summary. Given the context of clinical laboratory testing, it's highly likely to be a prospective collection of human serum or plasma samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For an in vitro diagnostic (IVD) device like a C-Reactive Protein reagent, the "ground truth" is established by the results of a predicate quantitative assay, not by expert interpretation of images or patient data. The predicate method (Dade Behring CardioPhase hsCRP) serves as the reference standard whose results are compared to the new device.

4. Adjudication method for the test set

• Not Applicable. As this is a quantitative chemical assay, there is no "adjudication" in the sense of reconciling differing expert opinions. The comparison is directly between the numerical results of two laboratory methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is an IVD reagent (a laboratory test kit) for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, but framed differently. The "standalone performance" is essentially what's demonstrated in the Method Comparison and Imprecision studies. The SYNCHRON® Systems High Sensitivity Cardiac CRPH Reagent, in conjunction with the specified SYNCHRON LX 20 PRO System, UniCel® DxC 600/800 System(s), and SYNCHRON® Systems CAL 5 Plus, provides a quantitative result directly. There is no human intervention in the interpretation of the result to arrive at the CRP concentration, other than the standard laboratory procedures for running the test.

7. The type of ground truth used

• The ground truth for the method comparison study was the results obtained from the predicate device, Dade Behring CardioPhase hsCRP.
• For the imprecision study, the "ground truth" is the true concentration within the assayed samples, which the device aims to measure consistently. The reported mean values serve as the estimate of this truth for assessing variability.

8. The sample size for the training set

• Not explicitly stated/Not applicable in the AI sense. For an IVD reagent, there isn't a "training set" in the context of machine learning or AI algorithms. The "training" for such reagents involves optimizing the chemical formulation and assay parameters based on extensive laboratory testing and validation during development. The provided document shows the performance verification data.

9. How the ground truth for the training set was established

• Not applicable in the AI sense. As there's no "training set" for an AI algorithm, there's no ground truth established in that manner. The development and optimization of the reagent formulation and assay procedure would have involved internal validation against known standards and reference materials, but these are part of the reagent's analytical design, rather than a "training set" for an algorithm.

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